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CompletedNCT02205281PIHUpdated Aug 28, 2020

Partners in Health: A Couples-based Approach to Obesity Prevention

An interventional study of Lifestyle Intervention in Obesity, sponsored by California Polytechnic State University-San Luis Obispo. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-28.

Sponsored by California Polytechnic State University-San Luis Obispo · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this pilot study is to test the feasibility of an innovative, couples based approach to weight management during pregnancy. The primary hypothesis is that a couples-based behavioral weight management program will reduce the rate of gestational weight gain compared to standard care.

02

Conditions studied

  • Obesity

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Keywords

  • Overweight
  • Obese
  • Pregnancy
  • Weight Gain
  • Weight Loss
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 30 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

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Lead sponsor

California Polytechnic State University-San Luis Obispo is the lead sponsor of 29 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Pregnant Women

  • >18 years old
  • 15-22 weeks gestation
  • BMI >= 25
  • cohabitating with partner for at least 3 months or recently married
  • willing to consent

Non-pregnant Partner

  • BMI >= 25
  • cohabitating with partner for at least 3 months or recently married
  • willing to consent

Exclusion criteria

Exclusion Criteria:

  • Untreated medical or psychological problem
  • Inability to be physically active
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    Standard Care
  • Experimental
    Lifestyle Intervention

    Behavioral: Lifestyle Intervention

Interventions

  • BehavioralLifestyle Intervention

    The intervention is a multi-component program designed to prevent excessive gestational weight gain in overweight and obese women and to promote weight loss in their non-pregnant overweight and obese partners through modifications of diet, exercise, and behavioral strategies during pregnancy.

06

What researchers measure

Primary outcomes

  1. Gestational weight gain

    Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.

    Time frame: 16 weeks gestation, 35 weeks gestation

Secondary outcomes

  1. Partner's weight loss

    Weight lost by the non-pregnant partner during the study will be assessed by subtracting their weight at the 35 week gestation visit from their study entry weight.

    Time frame: study entry, when pregnant partner reaches 35 weeks gestation

07

Study locations

1 site
  • Cal Poly
    San Luis Obispo, California 93401, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02205281
Lead sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
Dignity Health- French Hospital Medical Center
Responsible party
Suzanne Phelan (Associate Professor, California Polytechnic State University-San Luis Obispo) — Principal investigator
First posted
Jul 31, 2014
Start date
Jun 2014
Primary completion
May 2018
Completion
May 2018
Last update
Aug 28, 2020

Study contacts

Suzanne Phelan, PhD
principal investigator · Cal Poly

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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